A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

GLB-002-01

Study GLB-002-01 is a first-in-human (FIH), phase 1, open-label, dose escalation and expansion clinical study, the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-002 monotherapy in participants with relapsed or refractory Non-Hodgkin lymphomas (R/R NHL).

2024-01-11

2026-01-31

2027-02-28

Recruiting

Early phase I

110

Inclusion Criteria: * Participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed. * Participants is ≥18 years of age at the time of signing the ICF. * Participants with histopathologically or immunohistochemically confirmed NHL according to 2016 World Health Organization (WHO) haematolymphoid tumors criteria classification (CLL/SLL diagnosis according to 2018 IWCLL) who have failed standard of care therapy or lack an effective treatment regimen. * Participants in Phase Ib screening period with measurable lesion, but no measurable nodal lesion limit for participants in Phase Ia. * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. * Life expectancy \> 3 months. * Good performance of major organs, including hematology, liver and kidney function, and coagulation. etc. * Participants are willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Receipt of anticancer medications/therapies such as chemotherapy, targeted therapy, immunotherapy, biologic therapy, or herbal agent ≤ 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002; or chimeric antigen receptor T cell therapy (CAR-T) within 3 months prior to the first dose of GLB-002. * Currently enrolled in any other investigational drug study or participation within the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002 (exception of participants who participated in only one investigational drug study with overall survival follow-up). * Participants with unresolved clinically significant toxicities of \> Grade 1 AE or not be recovered to baseline value from prior anticancer therapies with exception of alopecia or hyperpigmentation of the skin. * Participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period. * Participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy (except corticosteroids at a dose equivalent to 12 mg or less of prednisone per day). * Receipt of Autologous Stem Cell Transplantation (ASCT) within the last 3 months, or allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-002. * Participants with known active leukemic involvement in central nervous system (CNS). * Participants with peripheral neuropathy ≥ Grade 2 (Graded according to CTCAE version 5.0). * History of, or current active cancer other malignancy for the past 5 years, with the exception of curatively resected cancer in situ, including cervical carcinoma in situ, basal cell carcinoma of the skin, or prostate cancer in situ, etc * QT interval interval \>470 milliseconds (ms) using electrocardiographic (ECG) at Screening. * Participants has impaired cardiac function or clinically significant cardiac disease at current or within last 6 months. * Participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV). * Participants with known human immunodeficiency virus (HIV) infection. * Participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases * Participants with a condition that may affects the absorption, distribution, metabolism and excretion of GLB-002. * Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme (CYP)3A4/5 and/or P-glycoprotein (P-gp) within 7 days or 5 half-lives prior to the first dose of GLB-002, whichever is shorter. * Participants who have undergone major surgery within 28 days prior to the first dose of the GLB-002. * Pregnant or lactating women. * Participants who have cognitive impairment due to any psychiatric or neurological condition, including epilepsy and dementia, may limit their understanding, performance, and study compliance with the ICF. * Participants,in the opinion of the Investigator, who are unsuitable to participate in the study.

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2024-04-26